JP2020103834A - Blood purification device - Google Patents

Blood purification device Download PDF

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JP2020103834A
JP2020103834A JP2018248125A JP2018248125A JP2020103834A JP 2020103834 A JP2020103834 A JP 2020103834A JP 2018248125 A JP2018248125 A JP 2018248125A JP 2018248125 A JP2018248125 A JP 2018248125A JP 2020103834 A JP2020103834 A JP 2020103834A
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temperature
heater
liquid
circuit
blood
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JP7154128B2 (en
Inventor
智洋 古橋
Tomohiro Furuhashi
智洋 古橋
秀人 真木
Hideto MAKI
秀人 真木
カヅィンツィ フェレンツ
Kazinczi Ferenc
カヅィンツィ フェレンツ
祐樹 江田
Yuki Eda
祐樹 江田
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Nikkiso Co Ltd
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Nikkiso Co Ltd
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Priority to JP2018248125A priority Critical patent/JP7154128B2/en
Priority to CN201980085953.3A priority patent/CN113226396A/en
Priority to EP19903507.2A priority patent/EP3903849B1/en
Priority to PCT/JP2019/033857 priority patent/WO2020137000A1/en
Priority to US17/418,032 priority patent/US20220088280A1/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/369Temperature treatment
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/14Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1654Dialysates therefor
    • A61M1/1656Apparatus for preparing dialysates
    • A61M1/166Heating
    • A61M1/1664Heating with temperature control
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/36Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621Extra-corporeal blood circuits
    • A61M1/3623Means for actively controlling temperature of blood
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/12General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/127General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/33Controlling, regulating or measuring
    • A61M2205/3368Temperature
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00General characteristics of the apparatus
    • A61M2205/36General characteristics of the apparatus related to heating or cooling
    • A61M2205/3653General characteristics of the apparatus related to heating or cooling by Joule effect, i.e. electric resistance

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  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Cardiology (AREA)
  • Urology & Nephrology (AREA)
  • Emergency Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

To provide a blood purification device in which failure of a liquid temperature adjustment for a supply liquid is difficult to occur.SOLUTION: A blood purification device comprises: a blood circuit 2 for extracorporeally circulating blood of a patient; a liquid supply circuit 4 for supplying a supply liquid to the blood circuit 2 or a blood purifier 3 provided on the blood circuit 2; and warming tools 65, 75 which are provided on the liquid supply circuit 4 for warming the supply liquid. The warming tools 65, 75 comprise: a heater 654 which is provided on a holding plane 651a being configured to hold a warming circuit 66 being a part of the liquid supply circuit 4 and for holding the warming circuit 66; a heater temperature detection part for detecting a temperature of the heater 654; and a liquid temperature detection temperature sensor 656 being provided at a position which is separated from the heater 654 on the holding plane 651a and contacts the warming circuit 66 on a downstream side of a liquid feeding direction of a warmed part warmed by the heater 654, and capable of detecting a temperature of the supply liquid flowing in the warming circuit 66.SELECTED DRAWING: Figure 4

Description

本発明は、血液浄化装置に関する。 The present invention relates to a blood purification device.

血液浄化装置において、透析液や補充液の温度が低いと、患者に戻される血液の温度が低下して患者が寒さを感じる等の不具合が生じる。そこで、従来、透析液や補充液等の供給液を加温する加温器を備えた血液浄化装置が用いられている(例えば、特許文献1参照)。 In the blood purification device, when the temperature of the dialysate or the replenisher is low, the temperature of the blood returned to the patient is lowered, and the patient feels cold. Therefore, conventionally, a blood purification apparatus having a warmer for heating a supply liquid such as a dialysate or a replenisher has been used (see, for example, Patent Document 1).

特開2017−080266号公報JP, 2017-080266, A

血液浄化装置では、加温器と別体に液温検出用の温度センサ(例えばクリップ式の温度センサ等)を有し、供給液の温度が設定温度となるように加温器を制御するものが知られている。しかし、このような血液浄化装置では、液温検出用の温度センサを取り付け忘れたり、正常な取り付けがなされなかったりする場合があった。この場合、透析液や補充液等の供給液の液温を正しく制御でなくなるおそれがあり、改善が望まれる。 The blood purification device has a temperature sensor (for example, a clip-type temperature sensor) for liquid temperature detection separately from the warmer, and controls the warmer so that the temperature of the supply liquid reaches a set temperature. It has been known. However, in such a blood purification apparatus, there are cases where the temperature sensor for detecting the liquid temperature is forgotten to be attached, or normal attachment is not performed. In this case, the liquid temperature of the supply liquid such as dialysate or replenisher may not be controlled correctly, and improvement is desired.

そこで、本発明は、供給液の液温調整の不具合が発生しにくい血液浄化装置を提供することを目的とする。 Therefore, it is an object of the present invention to provide a blood purification device in which the problem of adjusting the temperature of the supply liquid is unlikely to occur.

上記課題を解決することを目的として、請求項1に係る発明は、患者の血液を体外循環させる血液回路と、前記血液回路、あるいは前記血液回路に設けられた血液浄化器に供給液を供給する液供給回路と、前記液供給回路に設けられ、供給液を加温する加温器と、を備え、前記加温器は、前記液供給回路の一部である加温用回路を挟持するように構成されており、前記加温用回路を狭持する狭持面に設けられたヒータと、前記ヒータの温度を検出可能なヒータ温度検出部と、前記狭持面の前記ヒータと離間した位置であって、かつ、前記加温用回路を狭持した際に、前記ヒータにより加温される部分よりも送液方向下流側の前記加温用回路に当接する位置に設けられ、前記加温用回路を流れる供給液の温度を検出可能な液温検出用温度センサと、を有する、血液浄化装置を提供する。 In order to solve the above problems, the invention according to claim 1 supplies a supply liquid to a blood circuit for extracorporeally circulating a patient's blood, the blood circuit, or a blood purifier provided in the blood circuit. A liquid supply circuit and a warmer provided in the liquid supply circuit for heating the supply liquid are provided, and the warmer sandwiches a heating circuit which is a part of the liquid supply circuit. And a heater provided on a holding surface that holds the heating circuit, a heater temperature detection unit that can detect the temperature of the heater, and a position of the holding surface that is separated from the heater. In addition, when the heating circuit is held, the heating circuit is provided at a position abutting the heating circuit on the downstream side in the liquid feeding direction with respect to the portion heated by the heater. There is provided a blood purification device having a liquid temperature detecting temperature sensor capable of detecting the temperature of a supply liquid flowing through a power supply circuit.

請求項2に係る発明は、前記ヒータ温度検出部で検出した前記ヒータの温度と、前記液温検出用温度センサで検出した供給液の温度とを基に、前記加温用回路の前記加温器への装着の有無を検知する加温器装着検知部を備えた、請求項1に記載の血液浄化装置である。 According to a second aspect of the present invention, based on the temperature of the heater detected by the heater temperature detection unit and the temperature of the supply liquid detected by the temperature sensor for liquid temperature detection, the heating of the heating circuit is performed. The blood purification apparatus according to claim 1, further comprising a warming device mounting detection unit that detects whether or not the device is mounted on the device.

請求項3に係る発明は、前記加温器装着検知部は、前記加温器が加温を開始した後、前記ヒータ温度検出部が検出した温度が所定の上限温度に到達し、かつ、前記加温器の加温開始時からの前記液温検出用温度センサの検出温度の上昇が、所定の異常判定閾値未満であるとき、前記加温用回路が前記加温器に装着されていないと判定する、請求項2に記載の血液浄化装置である。 In the invention according to claim 3, in the warmer mounting detection unit, after the warmer starts heating, the temperature detected by the heater temperature detection unit reaches a predetermined upper limit temperature, and When the rise in the temperature detected by the temperature sensor for liquid temperature detection from the start of heating of the warmer is less than a predetermined abnormality determination threshold value, the warming circuit is not mounted on the warmer. The blood purification apparatus according to claim 2, wherein the determination is performed.

請求項4に係る発明は、前記液温検出用温度センサで検出した供給液の温度が、予め設定された設定温度となるように、前記ヒータの温度を制御するヒータ制御部を備え、前記ヒータ制御部は、使用する供給液に応じて、前記ヒータ温度の上限値を設定可能に構成されている、請求項1乃至3の何れか1項に記載の血液浄化装置である。 According to a fourth aspect of the present invention, the heater control unit controls the temperature of the heater so that the temperature of the supply liquid detected by the temperature sensor for liquid temperature detection becomes a preset temperature, The control unit is the blood purification apparatus according to any one of claims 1 to 3, wherein an upper limit value of the heater temperature can be set according to a supply liquid used.

請求項5に係る発明は、前記ヒータ制御部は、使用する供給液が蛋白質成分を含むか否かに応じて、前記上限温度を変更可能に構成されている、請求項4に記載の血液浄化装置である。 The invention according to claim 5 is such that the heater control unit is configured to be able to change the upper limit temperature depending on whether or not the supply liquid to be used contains a protein component. It is a device.

請求項6に係る発明は、使用する供給液が蛋白質成分を含む場合、前記上限温度が46度未満とされ、使用する供給液が蛋白質成分を含まない場合、前記上限温度が46度以上とされる、請求項5に記載の血液浄化装置である。 In the invention according to claim 6, the upper limit temperature is less than 46 degrees when the feed solution used contains a protein component, and the upper limit temperature is 46 degrees or more when the feed solution used does not contain a protein component. The blood purification apparatus according to claim 5, wherein

請求項7に係る発明は、前記ヒータ温度検出部が、前記ヒータの加温領域内に設けられたヒータ用温度センサである、請求項1乃至6の何れか1項に記載の血液浄化装置である。 The invention according to claim 7 is the blood purification apparatus according to any one of claims 1 to 6, wherein the heater temperature detection unit is a temperature sensor for a heater provided in a heating region of the heater. is there.

請求項1に係る発明によれば、供給液の液温調整の不具合が発生しにくい血液浄化装置を提供できる。 According to the invention of claim 1, it is possible to provide the blood purification device in which the trouble of adjusting the liquid temperature of the supply liquid is unlikely to occur.

請求項2に係る発明によれば、加温用回路の前記加温器への装着の有無を検知することができる。 According to the invention of claim 2, it is possible to detect whether or not the warming circuit is attached to the warmer.

請求項3に係る発明によれば、加温用回路の前記加温器への装着の有無を精度よく検知することができる。 According to the invention of claim 3, it is possible to accurately detect whether or not the heating circuit is attached to the warmer.

請求項4乃至6に係る発明によれば、蛋白質成分を含む供給液を使用した場合に、蛋白質成分が凝固してしまうことを抑制できる。 According to the inventions of claims 4 to 6, it is possible to suppress the coagulation of the protein component when the supply liquid containing the protein component is used.

請求項7に係る発明によれば、ヒータ温度検出部を容易かつ低コストに実現できる。 According to the invention of claim 7, the heater temperature detecting portion can be realized easily and at low cost.

本発明の一実施の形態に係る血液浄化装置の概略構成図である。1 is a schematic configuration diagram of a blood purification device according to an embodiment of the present invention. 図1の血液浄化装置の外観を示す図である。It is a figure which shows the external appearance of the blood purification apparatus of FIG. 加温用回路の平面図である。It is a top view of a heating circuit. (a)は、透析液加温器の斜視図であり、(b)はそのA部拡大図である。(A) is a perspective view of a dialysate warmer, (b) is the A section enlarged view. (a)は、加温用回路未装着の状態でのヒータ用温度センサ、及び液温検出用温度センサの検出値の変化を示すグラフ図であり、(b)は、加温用回路を装着した状態でのヒータ用温度センサ、及び液温検出用温度センサの検出値の変化を示すグラフ図である。(A) is a graph which shows the change of the detected value of the temperature sensor for heaters and the temperature sensor for liquid temperature detection in the state where a heating circuit is not mounted, (b) is a heating circuit mounted It is a graph figure which shows the change of the detected value of the temperature sensor for heaters in the state which carried out, and the temperature sensor for liquid temperature detection.

[実施の形態]
以下、本発明の実施の形態を添付図面にしたがって説明する。
[Embodiment]
Embodiments of the present invention will be described below with reference to the accompanying drawings.

図1は、本実施の形態に係る血液浄化装置の概略構成図である。図1に示すように、血液浄化装置1は、患者の血液を体外循環させる血液回路2と、血液回路2に設けられ血液を浄化する血液浄化器3と、血液浄化器3、あるいは血液回路2に供給液を供給する液供給回路4と、血液浄化器3から排液が排出される排液回路5と、を備えている。血液回路2、液供給回路4(後述する透析液回路6と補充液回路7)、及び排液回路5は、可撓性を有するチューブを用いて構成されている。 FIG. 1 is a schematic configuration diagram of the blood purification device according to the present embodiment. As shown in FIG. 1, the blood purification apparatus 1 includes a blood circuit 2 for extracorporeally circulating a patient's blood, a blood purifier 3 provided in the blood circuit 2 for purifying blood, the blood purifier 3, or the blood circuit 2. A liquid supply circuit 4 for supplying a supply liquid to the blood and a drainage circuit 5 for discharging drainage from the blood purifier 3. The blood circuit 2, the liquid supply circuit 4 (the dialysate circuit 6 and the replenisher circuit 7 which will be described later), and the drainage circuit 5 are configured by using flexible tubes.

血液回路2の一端には、動脈側穿刺針21が設けられ、他端には静脈側穿刺針22が設けられている。また、血液回路2には、動脈側穿刺針21側から静脈側穿刺針22側にかけて、第1気泡検出装置23、血液ポンプ24、血液浄化器3、気液分離器25、第2気泡検出装置26が順次設けられている。第1気泡検出装置23及び第2気泡検出装置26は、気泡を検出する気泡検出センサを有し、気泡を検出したときに血液回路2をクランプする(挟み込んで閉塞する)機構を有している。 An arterial puncture needle 21 is provided at one end of the blood circuit 2, and a vein puncture needle 22 is provided at the other end. In the blood circuit 2, the first air bubble detection device 23, the blood pump 24, the blood purifier 3, the gas-liquid separator 25, and the second air bubble detection device from the artery side puncture needle 21 side to the vein side puncture needle 22 side. 26 are sequentially provided. The first bubble detection device 23 and the second bubble detection device 26 have a bubble detection sensor for detecting bubbles and a mechanism for clamping (sandwiching and closing) the blood circuit 2 when detecting bubbles. ..

血液ポンプ24は、チューブをしごいて血液を血液浄化器3側へと流動させる蠕動型のポンプからなる。血液浄化器3は、ダイアライザとも呼称されるものであり、図示しない血液浄化膜を介して血液と透析液とを接触させることで、血液を浄化するものである。気液分離器25は、気泡を除去し液体のみを静脈側穿刺針22側に通すように構成されている。 The blood pump 24 is a peristaltic pump that squeezes a tube to flow blood to the blood purifier 3 side. The blood purifier 3 is also called a dialyzer, and purifies the blood by bringing the blood and the dialysate into contact with each other via a blood purification membrane (not shown). The gas-liquid separator 25 is configured to remove bubbles and pass only the liquid to the venous puncture needle 22 side.

本実施の形態では、血液浄化装置1で様々な治療を可能とするため、液供給回路4として、透析液を供給する透析液回路6と、補充液を供給する補充液回路7の両回路を有している。ただし、血液浄化装置1は、透析液回路6と補充液回路7のどちらか一方のみを有していてもよい。 In the present embodiment, in order to enable various treatments with the blood purification device 1, as the liquid supply circuit 4, both a dialysate circuit 6 for supplying a dialysate and a replenisher circuit 7 for supplying a replenisher are provided. Have However, the blood purification device 1 may have only one of the dialysate circuit 6 and the replenisher circuit 7.

透析液回路6の一端には、透析液を収容する透析液収容バッグ61が接続されている。透析液回路6の他端は、血液浄化器3の透析液導入口に接続されている。透析液回路6には、透析液収容バッグ61側から血液浄化器3側にかけて、透析液移送ポンプ62、透析液を一時的に貯留する透析液小分けチャンバ63、透析液ポンプ64、透析液加温器65が順次設けられている。 A dialysate storage bag 61 for storing dialysate is connected to one end of the dialysate circuit 6. The other end of the dialysate circuit 6 is connected to the dialysate inlet of the blood purifier 3. In the dialysate circuit 6, the dialysate transfer pump 62, the dialysate subdivision chamber 63 for temporarily storing the dialysate, the dialysate pump 64, the dialysate warming from the dialysate storage bag 61 side to the blood purifier 3 side. The device 65 is sequentially provided.

透析液移送ポンプ62及び透析液ポンプ64は、チューブをしごいて透析液を流動させる蠕動型のポンプからなる。透析液移送ポンプ62は、透析液収容バッグ61内の透析液を透析液小分けチャンバ63に移送するために用いられる。透析液ポンプ64は、透析液小分けチャンバ63内の透析液を血液浄化器3側に流動させるために用いられる。透析液小分けチャンバ63を有することで、治療を中断させずに透析液収容バッグ61を交換することが可能になる。透析液加温器65は、患者に戻す血液の温度を下げてしまわないように、透析液を適宜な温度に加温するためのものであり、本発明の加温器の一態様である。透析液加温器65の詳細については、後述する。 The dialysate transfer pump 62 and the dialysate pump 64 are peristaltic pumps that squeeze the tubes to flow the dialysate. The dialysate transfer pump 62 is used to transfer the dialysate in the dialysate storage bag 61 to the dialysate subdivision chamber 63. The dialysate pump 64 is used to flow the dialysate in the dialysate subdivision chamber 63 to the blood purifier 3 side. By having the dialysate subdivision chamber 63, the dialysate storage bag 61 can be replaced without interrupting the treatment. The dialysate warmer 65 is for warming the dialysate to an appropriate temperature so as not to lower the temperature of blood returned to the patient, and is one aspect of the warmer of the present invention. Details of the dialysate warmer 65 will be described later.

補充液回路7の一端には、補充液を収容する補充液収容バッグ71が接続されている。補充液収容バッグ71の下流の補充液回路7には、補充液移送ポンプ72、補充液を一時的に貯留する補充液小分けチャンバ73、補充液ポンプ74、補充液加温器75、補充液用気液分離器76が順次設けられている。 A replenisher solution storage bag 71 for replenisher solution is connected to one end of the replenisher solution circuit 7. In the replenishment liquid circuit 7 downstream of the replenishment liquid storage bag 71, a replenishment liquid transfer pump 72, a replenishment liquid subdivision chamber 73 for temporarily storing the replenishment liquid, a replenishment liquid pump 74, a replenishment liquid warmer 75, and A gas-liquid separator 76 is sequentially provided.

また、補充液回路7は、補充液用気液分離器76の下流で分岐し、分岐した一方の補充液回路7である前補液回路7aの端部は、血液浄化器3と血液ポンプ24の間の血液回路2に接続されている。前補液回路7aには、前補液用ポンプ77が設けられている。分岐した他方の補充液回路7である後補液回路7bの端部は、血液回路2の気液分離器25に接続されている。 Further, the replenishment liquid circuit 7 is branched downstream of the gas-liquid separator for replenishment liquid 76, and one end of the branching replenishment liquid circuit 7 that is the front replenishment liquid circuit 7 a is connected to the blood purifier 3 and the blood pump 24. It is connected to the blood circuit 2 in between. The front replacement fluid circuit 7a is provided with a front replacement fluid pump 77. The end of the post-replenishment fluid circuit 7b, which is the other branched replenishment fluid circuit 7, is connected to the gas-liquid separator 25 of the blood circuit 2.

補充液移送ポンプ72、補充液ポンプ74、及び前補液用ポンプ77は、チューブをしごいて透析液を流動させる蠕動型のポンプからなる。補充液移送ポンプ72は、補充液収容バッグ71内の補充液を補充液小分けチャンバ73に移送するために用いられる。補充液ポンプ74は、補充液小分けチャンバ73内の補充液を血液回路2側に流動させるために用いられる。前補液用ポンプ77は、血液浄化器3の上流側の血液回路2に補充液を供給する「前補液」を行う際に駆動される。前補液用ポンプ77を駆動しない場合、補充液ポンプ74にて送液された補充液は後補液回路7bを通り、血液浄化器3の下流側の血液回路2(ここでは気液分離器25)に補充液を供給する「後補液」が行われる。 The replenishing liquid transfer pump 72, the replenishing liquid pump 74, and the pre-replacement liquid pump 77 are peristaltic pumps that squeeze the tube to flow the dialysate. The replenishment liquid transfer pump 72 is used to transfer the replenishment liquid in the replenishment liquid storage bag 71 to the replenishment liquid subdivision chamber 73. The replenisher pump 74 is used for flowing the replenisher in the replenisher subdivision chamber 73 to the blood circuit 2 side. The pre-replacement fluid pump 77 is driven when performing “pre-replacement fluid” that supplies replenishment fluid to the blood circuit 2 on the upstream side of the blood purifier 3. When the front replacement fluid pump 77 is not driven, the replacement fluid sent by the replacement fluid pump 74 passes through the rear replacement fluid circuit 7b, and the blood circuit 2 on the downstream side of the blood purifier 3 (here, the gas-liquid separator 25). "Post-replacement fluid" is performed to supply the replenisher fluid to the.

補充液小分けチャンバ73を有することで、治療を中断させずに補充液収容バッグ71を交換することが可能になる。補充液加温器75は、患者に戻す血液の温度を下げてしまわないように、補充液を適宜な温度に加温するためのものであり、本発明の加温器の一態様である。補充液用気液分離器76は、補充液から気泡を分離除去するためのものである。 By having the replenisher subdividing chamber 73, it becomes possible to replace the replenisher containing bag 71 without interrupting the treatment. The replenisher solution warmer 75 is for heating the replenisher solution to an appropriate temperature so as not to lower the temperature of the blood returned to the patient, and is one aspect of the warmer of the present invention. The replenisher gas-liquid separator 76 is for separating and removing air bubbles from the replenisher.

排液回路5の一端は、血液浄化器3の排液出口に接続されている。血液浄化器3の下流の排液回路5には、排液ポンプ51、排液を一時的に貯留する排液小分けチャンバ52、排出用ポンプ53が順次設けられている。排液回路5の他端は、装置外に排液を排出する排液出口54となっている。 One end of the drainage circuit 5 is connected to the drainage outlet of the blood purifier 3. In the drainage circuit 5 downstream of the blood purifier 3, a drainage pump 51, a drainage subdivision chamber 52 for temporarily storing drainage, and a drainage pump 53 are sequentially provided. The other end of the drainage circuit 5 serves as a drainage outlet 54 for discharging drainage to the outside of the device.

排液ポンプ51及び排出用ポンプ53は、チューブをしごいて透析液を流動させる蠕動型のポンプからなる。排液ポンプ51は、排液を排液小分けチャンバ52に送液するために用いられる。排出用ポンプ53は、排液小分けチャンバ52内の排液を排液出口54側へ排出するために用いられる。 The drainage pump 51 and the drainage pump 53 are peristaltic type pumps that squeeze a tube to flow dialysate. The drainage pump 51 is used to feed the drainage to the drainage subdivision chamber 52. The drainage pump 53 is used to drain the drainage in the drainage subdivision chamber 52 to the drainage outlet 54 side.

また、血液浄化装置1は、供給液の供給量と、排液の排出量とを基に、除水量を検出する除水量検出部10を有している。除水量検出部10は、上述の各小分けチャンバ63,73,52と、各小分けチャンバ63,73,52の合計の重さを検出可能な重さ検出機構としての荷重計8と、除水量演算部91と、を有している。 The blood purification apparatus 1 also includes a water removal amount detection unit 10 that detects the water removal amount based on the supply amount of the supply liquid and the discharge amount of the drainage liquid. The water removal amount detection unit 10 includes the above-described subdivision chambers 63, 73, 52, a load meter 8 as a weight detection mechanism capable of detecting the total weight of the subdivision chambers 63, 73, 52, and a water removal amount calculation. And a section 91.

荷重計8は、透析液小分けチャンバ63、補充液小分けチャンバ73、及び排液小分けチャンバ52の合計の重さを検出可能に構成されている。荷重計8の検出値は、制御装置9に出力される。 The load meter 8 is configured to detect the total weight of the dialysate subdivision chamber 63, the replenisher subdivision chamber 73, and the drainage subdivision chamber 52. The detection value of the load meter 8 is output to the control device 9.

除水量演算部91は、荷重計8の検出値の時間変化を検出することで、除水量を検出する。除水量演算部91は、制御装置9に搭載され、CPU等の演算素子、メモリ、記憶装置、ソフトウェア、インターフェイス等を適宜組み合わせて実現される。 The water removal amount calculation unit 91 detects the water removal amount by detecting the time change of the detection value of the load meter 8. The water removal amount calculation unit 91 is mounted on the control device 9, and is realized by appropriately combining a calculation element such as a CPU, a memory, a storage device, software, an interface, and the like.

また、血液浄化装置1は、除水量検出部10で検出した除水量が、目標除水量と一致するように、液供給ポンプ(透析液ポンプ64及び補充液ポンプ74)と排液ポンプ51の一方または両方のポンプ速度(ポンプ流量)を補正する除水量制御部92を備えている。除水量制御部92は、制御装置9に搭載され、CPU等の演算素子、メモリ、記憶装置、ソフトウェア、インターフェイス等を適宜組み合わせて実現される。 Further, the blood purification device 1 uses one of the liquid supply pump (dialysate pump 64 and replenisher pump 74) and the drainage pump 51 so that the water removal amount detected by the water removal amount detection unit 10 matches the target water removal amount. Alternatively, a water removal amount control unit 92 that corrects both pump speeds (pump flow rates) is provided. The water removal amount control unit 92 is mounted on the control device 9 and is realized by appropriately combining an arithmetic element such as a CPU, a memory, a storage device, software, and an interface.

(加温器とその制御)
ここで、透析液加温器65とその制御について説明する。なお、補充液加温器75とその制御についてはここでは説明を省略するが、以下に述べる透析液加温器65と同様の構造であり、透析液加温器65と同様の制御が行われている。
(Heater and its control)
Here, the dialysate warmer 65 and its control will be described. Although the replenisher warmer 75 and its control are not described here, it has the same structure as the dialysate warmer 65 described below, and the same control as the dialysate warmer 65 is performed. ing.

図2は、血液浄化装置1の外観を示す図である。図3は、加温用回路の平面図である。図4(a)は、透析液加温器65の斜視図であり、図4(b)はそのA部拡大図である。図2乃至図4に示すように、透析液加温器65は、血液浄化装置1の側方に開閉可能に設けられている。 FIG. 2 is a diagram showing an appearance of the blood purification device 1. FIG. 3 is a plan view of the heating circuit. FIG. 4A is a perspective view of the dialysate warmer 65, and FIG. 4B is an enlarged view of part A thereof. As shown in FIGS. 2 to 4, the dialysate warmer 65 is provided laterally of the blood purification device 1 so as to be openable and closable.

透析液加温器65は、透析液回路6の一部である加温用回路66を挟持するように構成されている。図3に示すように、加温用回路66は、加温バッグとも呼称されるものであり、例えば、可撓性を有するシートを2枚重ねて溶着することによって流路66aが形成されている。流路66aは蛇行するように形成されており、流路66aの一方の端部が透析液の流入口66b、他方の端部が透析液の流出口66cとなっている。流入口66bには、透析液ポンプ64から延びるチューブ6aが接続され、流出口66cには、血液浄化器3に延びるチューブ6bが接続される。加温用回路66は、チューブ6a,6bと比較して柔らかい材質からなるため、透析液加温器65に装着し忘れて放置されていると、透析液が加温されないのみならず、なんらかの理由で破損してしまったり、あるいは外圧の影響や透析液が加温用回路66に溜まってしまう等して、意図した流量と異なる流量の透析液が血液浄化器3へと供給されてしまうおそれが生じる。そのため、加温用回路66を透析液加温器65に装着し忘れている場合には、ユーザにその旨を報知することが望まれる。 The dialysate warmer 65 is configured to sandwich a warming circuit 66 which is a part of the dialysate circuit 6. As shown in FIG. 3, the heating circuit 66 is also called a heating bag, and for example, the flow passage 66a is formed by stacking and welding two flexible sheets. .. The flow path 66a is formed to meander, and one end of the flow path 66a serves as a dialysate inlet 66b, and the other end serves as a dialysate outlet 66c. A tube 6a extending from the dialysate pump 64 is connected to the inflow port 66b, and a tube 6b extending to the blood purifier 3 is connected to the outflow port 66c. Since the heating circuit 66 is made of a softer material than the tubes 6a and 6b, if the dialyzer warming device 65 is forgotten to be attached and left unattended, not only the dialysate will not be heated, but for some reason. There is a risk that the dialysate may be supplied to the blood purifier 3 at a flow rate different from the intended flow rate due to damage to the blood purifier 3 due to external pressure or the dialysate pooling in the heating circuit 66. Occurs. Therefore, if the user forgets to attach the heating circuit 66 to the dialysate warmer 65, it is desired to inform the user of that fact.

透析液加温器65は、血液浄化装置1の側部に固定された固定部651と、固定部651の下部に設けられたヒンジ部653を介して、固定部651に回動可能に設けられた蓋部652と、を備えており、固定部651と蓋部652との間に加温用回路66を挟持するように構成されている。固定部651の狭持面(加温用回路66を狭持する面)651aには、加温用回路66を加温して加温用回路66内を流通する透析液を加温するための板状のヒータ654が設けられている。なお、ここでは、固定部651にヒータ654が設けられている場合を説明するが、ヒータ654は蓋部652に設けられていてもよいし、固定部651と蓋部652の両方に設けられていてもよい。 The dialysate warmer 65 is rotatably provided on the fixed portion 651 via a fixed portion 651 fixed to a side portion of the blood purification apparatus 1 and a hinge portion 653 provided below the fixed portion 651. And a lid portion 652, and the heating circuit 66 is sandwiched between the fixing portion 651 and the lid portion 652. The holding surface 651a of the fixing portion 651 (the surface that holds the heating circuit 66) is for heating the heating circuit 66 and for heating the dialysate flowing in the heating circuit 66. A plate-shaped heater 654 is provided. Although the case where the heater 654 is provided in the fixed portion 651 will be described here, the heater 654 may be provided in the lid portion 652 or may be provided in both the fixed portion 651 and the lid portion 652. May be.

ヒータ654は、加温用回路66を狭持した際に、加温用回路66の流路66a(蛇行している部分)を挟み込むように設けられている。なお、ここでは、固定部651及び蓋部652の両方にヒータ654を設けているが、何れか一方のみにヒータ654が設けられていてもよい。 The heater 654 is provided so as to sandwich the flow path 66 a (meandering portion) of the heating circuit 66 when the heating circuit 66 is held. Although the heater 654 is provided on both the fixing portion 651 and the lid portion 652 here, the heater 654 may be provided on only one of them.

また、透析液加温器65は、ヒータ654の温度を検出可能なヒータ温度検出部としてのヒータ用温度センサ655と、加温用回路66を流れる透析液の温度を検出可能な液温検出用温度センサ656と、を有している。 Further, the dialysate warmer 65 is a heater temperature sensor 655 as a heater temperature detector that can detect the temperature of the heater 654, and a liquid temperature detector that can detect the temperature of the dialysate flowing through the warming circuit 66. And a temperature sensor 656.

ヒータ用温度センサ655は、ヒータ654の加温領域内に設けられ、ヒータ654の温度を検出するものであり、例えばサーミスタである。ここでは、ヒータ用温度センサ655が、固定部651側(ヒータ654が設けられた側)に搭載されている場合を示しているが、蓋部652側(ヒータ654が設けられていない側)に搭載されていてもよい。また、複数のヒータ用温度センサ655を有していてもよい。なお、ヒータ温度検出部は、ヒータ用温度センサ655に限定されず、例えば、ヒータ654に供給される電流を検出する電流センサ等を用いて構成されてもよい。この場合、電流センサが検出する電流値に基づき、ヒータ654の温度を検出(推定)する。 The heater temperature sensor 655 is provided in the heating region of the heater 654, detects the temperature of the heater 654, and is, for example, a thermistor. Here, the heater temperature sensor 655 is shown mounted on the fixed portion 651 side (the side on which the heater 654 is provided), but on the lid portion 652 side (the side on which the heater 654 is not provided). It may be installed. Further, a plurality of heater temperature sensors 655 may be included. The heater temperature detection unit is not limited to the heater temperature sensor 655, and may be configured using, for example, a current sensor that detects the current supplied to the heater 654. In this case, the temperature of the heater 654 is detected (estimated) based on the current value detected by the current sensor.

液温検出用温度センサ656は、狭持面651aのヒータ654と離間した位置であって、かつ、加温用回路66を狭持した際に、ヒータ654により加温される部分よりも送液方向下流側の加温用回路66に当接する位置に設けられている。つまり、血液浄化装置1では、加温用回路66を透析液加温器65に装着すると、他の操作を行わずとも液温検出用温度センサ656が加温用回路66に当接し、透析液の温度を検出可能な状態になる。そのため、透析液加温器65と別体に液温検出用温度センサ656を設けた場合のように、センサの付け忘れや、装着時の不具合といったヒューマンエラーが生じにくい。液温検出用温度センサ656は、例えばサーミスタである。 The liquid temperature detecting temperature sensor 656 is located at a position separated from the heater 654 of the holding surface 651a, and when the heating circuit 66 is held, the liquid temperature is higher than the portion heated by the heater 654. It is provided at a position in contact with the heating circuit 66 on the downstream side in the direction. That is, in the blood purification apparatus 1, when the warming circuit 66 is attached to the dialysate warmer 65, the temperature sensor 656 for detecting the fluid temperature abuts on the warming circuit 66 without any other operation, and the dialysate warms up. The temperature can be detected. Therefore, as in the case where the temperature sensor 656 for detecting the liquid temperature is provided separately from the dialysate warmer 65, a human error such as forgetting to attach the sensor or a defect at the time of mounting is unlikely to occur. The liquid temperature detecting temperature sensor 656 is, for example, a thermistor.

ヒータ654の熱の影響を抑制するため、液温検出用温度センサ656は、なるべくヒータ654に対して熱的に遮断された位置に設けられることが望ましい。本実施の形態では、ヒータ654の周囲を覆う部材(ヒータ654の周りの狭持面651aを構成する部材)を断熱性の高い樹脂製の部材で構成し、当該部材を介してヒータ654から離間した位置に、液温検出用温度センサ656を設けた。液温検出用温度センサ656は、加温用回路66の表面に当接して、その当接部分の温度を検出する。加温用回路66は薄いシートからなるため、加温用回路66の表面の温度は、加温用回路66内を流通する透析液の温度と略等しくなる。 In order to suppress the influence of heat from the heater 654, it is desirable that the liquid temperature detecting temperature sensor 656 be provided at a position that is thermally shielded from the heater 654 as much as possible. In the present embodiment, the member that covers the periphery of the heater 654 (the member that forms the sandwiching surface 651a around the heater 654) is made of a resin member having a high heat insulation property, and is separated from the heater 654 via the member. A liquid temperature detecting temperature sensor 656 was provided at the position. The liquid temperature detecting temperature sensor 656 contacts the surface of the heating circuit 66 and detects the temperature of the contact portion. Since the heating circuit 66 is made of a thin sheet, the temperature of the surface of the heating circuit 66 becomes substantially equal to the temperature of the dialysate flowing in the heating circuit 66.

血液浄化装置1は、液温検出用温度センサ656で検出した透析液の温度が、予め設定された設定温度となるように、ヒータ654の温度を制御するヒータ制御部93を備えている。ヒータ制御部93は、例えば、設定温度と透析液の温度との差分に基づいてヒータ目標温度を設定し、ヒータ用温度センサ655で検出されるヒータ654の温度がヒータ目標温度となるように、ヒータ654の温度制御(供給電流の制御等)を行う。ヒータ制御部93は、制御装置9に搭載され、CPU等の演算素子、メモリ、記憶装置、ソフトウェア、インターフェイス等を適宜組み合わせて実現される。 The blood purification apparatus 1 includes a heater control unit 93 that controls the temperature of the heater 654 so that the temperature of the dialysate detected by the temperature sensor for liquid temperature detection 656 becomes a preset temperature. The heater control unit 93 sets the heater target temperature based on the difference between the set temperature and the dialysate temperature, for example, so that the temperature of the heater 654 detected by the heater temperature sensor 655 becomes the heater target temperature. Temperature control of the heater 654 (control of supply current, etc.) is performed. The heater control unit 93 is mounted on the control device 9 and is realized by appropriately combining an arithmetic element such as a CPU, a memory, a storage device, software, and an interface.

ヒータ制御部93は、使用する供給液(透析液や補充液)に応じて、ヒータ654の温度の上限値(上限温度という)を設定可能に構成されているとよい。さらに、ヒータ制御部93は、使用する供給液が蛋白質成分を含むか否かに応じて、上限温度を変更可能に構成されているとよい。 The heater control unit 93 may be configured to be able to set an upper limit value (referred to as an upper limit temperature) of the temperature of the heater 654 according to the supply liquid (dialysis liquid or replenishing liquid) used. Furthermore, the heater control unit 93 may be configured to be able to change the upper limit temperature depending on whether or not the supply liquid used contains a protein component.

具体的には、PE(血漿交換療法)、PA(血漿吸着法)、あるいはDFPP(二重濾過血漿交換)と呼称される治療モードにおいては、アルプミン等の蛋白質成分を含む新鮮凍結血漿を供給液として用いる。アルブミンなどタンパク質成分は、46度以上の高熱で加温すると白く凝固してしまう性質がある。なお、蛋白質成分が凝固する温度は、蛋白質成分によって異なり、41℃〜46℃程度である。よって、使用する供給液が蛋白質成分を含む場合には、上限温度を46℃未満、より好ましくは40℃以下とするとよい。他方、持続的血液透析(CHD)、CHDF(持続的血液透析ろ過)、あるいはCHF(持続的血液ろ過)では、蛋白質成分を含まない透析液を用いるため、上限温度を46度以上とすることができる。 Specifically, in a treatment mode called PE (plasma exchange therapy), PA (plasma adsorption method), or DFPP (double filtration plasma exchange), a fresh frozen plasma containing a protein component such as alpmin is supplied. Used as. A protein component such as albumin has the property of whitening and coagulating when heated with high heat of 46° C. or higher. The temperature at which the protein component coagulates depends on the protein component and is about 41°C to 46°C. Therefore, when the feed liquid used contains a protein component, the upper limit temperature is preferably lower than 46°C, more preferably 40°C or lower. On the other hand, in continuous hemodialysis (CHD), CHDF (continuous hemodiafiltration), or CHF (continuous hemofiltration), since a dialysate containing no protein component is used, the upper limit temperature may be 46°C or higher. it can.

また、例えば、20℃未満の低温の供給液を加温する際には、ヒータ654の温度を46℃以上に加温する必要がある場合がある。ただし、加温量が大きすぎると片付け時等にユーザが加温器65,75の表面を触った際に火傷をしてしまうというリスクがあるため、ヒータ654の温度は、火傷のリスクのない温度、例えば51℃未満に制御されることが望まれる。ヒータ制御部93は、例えば、ヒータ用温度センサ655の検出温度が51℃以上となったとき、ヒータ654による加温を停止するように構成される。 In addition, for example, when heating the low temperature supply liquid of less than 20° C., it may be necessary to heat the temperature of the heater 654 to 46° C. or higher. However, if the heating amount is too large, there is a risk that the user will get burned when touching the surfaces of the warmers 65 and 75 at the time of cleaning up, so that the temperature of the heater 654 does not have a risk of burns. It is desired to control the temperature, for example below 51°C. The heater control unit 93 is configured to stop heating by the heater 654 when the temperature detected by the heater temperature sensor 655 is 51° C. or higher, for example.

なお、血液が体外循環する血液回路2に合流する時点の供給液の温度は、46℃未満になるよう制御する必要がある。これは、46℃以上の供給液が血液に接すると、赤血球が破壊される溶血と呼ばれる現象が生じてしまうためである。そのため、血液回路2への合流時点で供給液の温度が46℃未満となるように、液温検出用温度センサ656の検出値を監視する必要がある。ヒータ制御部93は、例えば、液温検出用温度センサ656の検出温度が46℃以上となったとき、ヒータ654による加温を停止するように構成される。 The temperature of the supply liquid at the time when the blood joins the blood circuit 2 that circulates extracorporeally needs to be controlled to be less than 46°C. This is because when a supply liquid of 46° C. or higher comes into contact with blood, a phenomenon called hemolysis in which red blood cells are destroyed occurs. Therefore, it is necessary to monitor the detection value of the liquid temperature detecting temperature sensor 656 so that the temperature of the supply liquid becomes less than 46° C. at the time of joining the blood circuit 2. The heater control unit 93 is configured to stop heating by the heater 654, for example, when the temperature detected by the temperature sensor 656 for liquid temperature detection is 46° C. or higher.

このように、ヒータ用温度センサ655にはヒータ654の過加熱を監視する役割があり、液温検出用温度センサ656には供給液の過加熱を監視する役割があるため、ヒータ温度検出部としてのヒータ用温度センサ655と、液温検出用温度センサ656とが独立して設けられていることが望まれる。 As described above, the heater temperature sensor 655 has a role of monitoring overheating of the heater 654, and the liquid temperature detecting temperature sensor 656 has a role of monitoring overheating of the supply liquid. It is desirable that the heater temperature sensor 655 and the liquid temperature detection temperature sensor 656 are independently provided.

また、血液浄化装置1は、ヒータ用温度センサ655で検出したヒータ654の温度と、液温検出用温度センサ656で検出した透析液の温度とを基に、加温用回路66の加温器65,75への装着の有無を検知する加温器装着検知部94を備えている。加温器装着検知部94は、制御装置9に搭載され、CPU等の演算素子、メモリ、記憶装置、ソフトウェア、インターフェイス等を適宜組み合わせて実現される。 Further, the blood purification apparatus 1 uses the warmer of the heating circuit 66 based on the temperature of the heater 654 detected by the heater temperature sensor 655 and the temperature of the dialysate detected by the liquid temperature detection temperature sensor 656. A warming device mounting detection unit 94 for detecting the presence/absence of mounting on the heating device 65, 75 is provided. The warmer attachment detection unit 94 is mounted on the control device 9 and is realized by appropriately combining an arithmetic element such as a CPU, a memory, a storage device, software, an interface, and the like.

加温器装着検知部94は、透析液ポンプ64が駆動されており、かつ、ヒータ654の温度を上昇させても透析液の温度が上昇しない場合に、加温用回路66の加温器65,75への装着がなされていないこと(つまり加温用回路66の装着忘れ)を検出する。 When the dialysate pump 64 is driven and the temperature of the dialysate does not rise even if the temperature of the heater 654 is raised, the warmer attachment detection unit 94 detects the warmer 65 of the warming circuit 66. , 75 is not attached (that is, the heating circuit 66 is forgotten to be attached).

図5(a)は、加温用回路66未装着の状態でのヒータ用温度センサ655、及び液温検出用温度センサ656の検出値の変化を示すグラフ図である。ここでは、透析液の流量を1000mL/hとした。図5(a)に示すように、加温用回路66未装着の状態では、ヒータ温度を上昇させても液温検出用温度センサ656の検出値が上昇せず、液温検出用温度センサ656の検出値は設定温度に到達しない。 FIG. 5A is a graph showing changes in the detected values of the heater temperature sensor 655 and the liquid temperature detecting temperature sensor 656 when the heating circuit 66 is not attached. Here, the flow rate of the dialysate was 1000 mL/h. As shown in FIG. 5A, in a state where the heating circuit 66 is not attached, the detection value of the liquid temperature detection temperature sensor 656 does not increase even if the heater temperature is increased, and the liquid temperature detection temperature sensor 656 is not used. The detected value of does not reach the set temperature.

図5(b)は、加温用回路66を装着した状態でのヒータ用温度センサ655、及び液温検出用温度センサ656の検出値の変化を示すグラフ図である。透析液の流量は、図5(a)の場合と同様に1000mL/hとした。図5(b)に示すように、加温用回路66を装着した状態では、ヒータ温度の上昇に伴って液温検出用温度センサ656の検出の検出値(液温)が上昇し、液温検出用温度センサ656の検出値(液温)が設定温度に到達している。このように、加温用回路66を装着した状態と、装着していない状態とでは、液温検出用温度センサ656の検出値が大きく変化する。加温器装着検知部94は、このような加温用回路66の装着の有無による液温検出用温度センサ656の検出値の変化を利用して、加温用回路66の加温器65,75への装着の有無を検出する。 FIG. 5B is a graph showing changes in the detected values of the heater temperature sensor 655 and the liquid temperature detection temperature sensor 656 in the state where the heating circuit 66 is mounted. The flow rate of the dialysate was 1000 mL/h as in the case of FIG. As shown in FIG. 5B, in the state where the heating circuit 66 is mounted, the detection value (liquid temperature) detected by the liquid temperature detection temperature sensor 656 rises as the heater temperature rises, and the liquid temperature rises. The detection value (liquid temperature) of the detection temperature sensor 656 has reached the set temperature. In this way, the detection value of the liquid temperature detecting temperature sensor 656 greatly changes between the state in which the heating circuit 66 is attached and the state in which it is not attached. The warmer mounting detection unit 94 uses the change in the detection value of the liquid temperature detecting temperature sensor 656 depending on whether or not the warming circuit 66 is mounted, and thus the warmer 65 of the warming circuit 66, The presence/absence of attachment to 75 is detected.

より具体的には、加温器装着検知部94は、加温器65,75が加温を開始した後、ヒータ用温度センサ655が検出した温度が所定の上限温度に到達し、かつ、加温器65,75の加温開始時からの液温検出用温度センサ656の検出温度の上昇が、所定の異常判定閾値未満であるとき、加温用回路66が加温器65,75に装着されていないと判定する。つまり、加温器装着検知部94は、ヒータ654の温度が十分に上昇しているにもかかわらず、液温検出用温度センサ656の検出温度が十分に上昇しないときに、加温用回路66が加温器65,75に装着されていないと判定する。なお、加温用回路66が加温器65,75に装着されていないと判定する具体的なアルゴリズムはこれに限定されず、例えば、加温前の供給液の温度、ヒータ用温度センサ655の検出温度、及び供給液の流量から、液温検出用温度センサ656を設けた位置での供給液の温度を推定し、その推定した温度と、実際に液温検出用温度センサ656で検出した温度の乖離が所定閾値よりもおおきくなったときに、加温用回路66が加温器65,75に装着されていないと判定する等してもよい。 More specifically, the warmer mounting detection unit 94 determines that the temperature detected by the heater temperature sensor 655 has reached a predetermined upper limit temperature after the warmers 65 and 75 start heating, and When the rise in the temperature detected by the temperature sensor 656 for detecting the liquid temperature from the start of heating the warmers 65, 75 is less than a predetermined abnormality determination threshold value, the warming circuit 66 is attached to the warmers 65, 75. It is determined that it has not been done. In other words, the warmer mounting detection unit 94 detects that the temperature of the heater 654 has risen sufficiently, but the detected temperature of the liquid temperature detecting temperature sensor 656 does not rise sufficiently, the warming circuit 66. Is not attached to the warmers 65 and 75. The specific algorithm for determining that the heating circuit 66 is not attached to the warmers 65 and 75 is not limited to this. For example, the temperature of the supply liquid before heating, the heater temperature sensor 655, and the like. The temperature of the supply liquid at the position where the temperature sensor for liquid temperature detection 656 is provided is estimated from the detected temperature and the flow rate of the supply liquid, and the estimated temperature and the temperature actually detected by the temperature sensor for liquid temperature detection 656 are estimated. When the deviation becomes larger than the predetermined threshold value, it may be determined that the heating circuit 66 is not attached to the warmers 65 and 75.

さらに、血液浄化装置1は、加温器装着検知部94が加温用回路66の装着忘れを検出したとき、警報を発する警報部11を備えている。警報部11は、光や音、振動、あるいはモニタ等の表示器111a(図2参照)に警告メッセージを表示する警報装置111と、警報装置111を制御する警報制御部112と、を有している。警報装置111は、例えば、音により警告音を発するブザーと、警告メッセージを表示する表示器とで構成される。警報制御部112は、例えば、ブザーを鳴動させ、表示器に警告メッセージを表示させる。警報制御部112は、制御装置9に搭載され、CPU等の演算素子、メモリ、記憶装置、ソフトウェア、インターフェイス等を適宜組み合わせて実現される。 Furthermore, the blood purification apparatus 1 includes an alarm unit 11 that issues an alarm when the warmer mounting detection unit 94 detects that the heating circuit 66 has not been mounted. The alarm unit 11 has an alarm device 111 that displays a warning message on a display device 111a (see FIG. 2) such as light, sound, vibration, or monitor, and an alarm control unit 112 that controls the alarm device 111. There is. The alarm device 111 includes, for example, a buzzer that emits a warning sound by sound and a display device that displays a warning message. The alarm control unit 112 causes, for example, a buzzer to sound and a warning message to be displayed on the display. The alarm control unit 112 is mounted on the control device 9 and is realized by appropriately combining an arithmetic element such as a CPU, a memory, a storage device, software, an interface and the like.

(実施の形態の作用及び効果)
以上説明したように、本実施の形態に係る血液浄化装置1では、供給液を加温する加温器65,75が、液供給回路4の一部である加温用回路66を挟持するように構成されており、加温用回路66を狭持する狭持面651aに設けられたヒータ654と、ヒータ654の温度を検出可能なヒータ温度検出部としてのヒータ用温度センサ655と、狭持面651aのヒータ654と離間した位置であって、かつ、加温用回路66を狭持した際に、ヒータ654により加温される部分よりも送液方向下流側の加温用回路66に当接する位置に設けられ、加温用回路66を流れる供給液の温度を検出可能な液温検出用温度センサ656と、を有している。
(Operation and Effect of Embodiment)
As described above, in the blood purification device 1 according to the present embodiment, the warmers 65 and 75 for heating the supply liquid sandwich the heating circuit 66 that is a part of the liquid supply circuit 4. And a heater 654 provided on the holding surface 651a that holds the heating circuit 66, a heater temperature sensor 655 as a heater temperature detection unit that can detect the temperature of the heater 654, and When the heating circuit 66 is held at a position separated from the heater 654 on the surface 651a, the heating circuit 66 is provided downstream of the portion heated by the heater 654 in the liquid feeding direction. And a liquid temperature detecting temperature sensor 656 which is provided at a contact position and is capable of detecting the temperature of the supply liquid flowing through the heating circuit 66.

加温器65,75に、ヒータ温度検出部(ヒータ用温度センサ655)と液温検出用温度センサ656の両方を搭載しておくことで、センサの付け忘れや取付時の不具合を抑制し、供給液の液温調整の不具合が発生しにくい血液浄化装置1を実現できる。また、両センサ655,656を用いて、加温用回路66の加温器65,75への装着忘れを検出することが可能になる。なお、液温検出用温度センサ656を加温器65,75と別体に設けた場合、ヒータ温度と液温との乖離が、加温用回路66の装着忘れによるものか、液温検出用温度センサ656の装着忘れや取付不具合によるものかを判断することができない。また、液温検出用温度センサ656を加温器65,75と別体に設けた場合、加温器65,75と液温検出用温度センサ656の取り付け位置との間で外気温の影響を受けてしまい、液温制御の誤差要因となってしまうが、本実施の形態では、加温器65,75に液温検出用温度センサ656を設けているため外気温の影響を受けにくく、使用する供給液に応じたより精度の高い液温調整(ヒータ制御)が可能となる。また、元々治療上で必要な液温検出用温度センサ656およびヒータ温度検出部の有無を判断することにより、別途センサ等を設ける必要がなくなり、加温用回路65,75の装着の有無を判定する機能を低コストに実現できる。 By mounting both the heater temperature detection unit (heater temperature sensor 655) and the liquid temperature detection temperature sensor 656 in the warmers 65 and 75, it is possible to prevent forgetting to attach the sensor or troubles during installation. It is possible to realize the blood purification device 1 in which the problem of adjusting the liquid temperature of the supply liquid is unlikely to occur. Further, by using both sensors 655 and 656, it becomes possible to detect the forgetting to attach the heating circuit 66 to the warmers 65 and 75. When the liquid temperature detecting temperature sensor 656 is provided separately from the warmers 65 and 75, the difference between the heater temperature and the liquid temperature may be due to forgetting to attach the heating circuit 66 or the liquid temperature detecting unit. It is impossible to determine whether the temperature sensor 656 is forgotten to be attached or due to an attachment defect. Further, when the liquid temperature detecting temperature sensor 656 is provided separately from the warmers 65, 75, the influence of the outside air temperature between the warmers 65, 75 and the mounting position of the liquid temperature detecting temperature sensor 656 is affected. However, in the present embodiment, since the temperature sensors 656 for detecting the liquid temperature are provided in the warmers 65 and 75, the temperature sensor 656 for detecting the liquid temperature is less likely to be affected by the outside air temperature. The liquid temperature can be adjusted (heater control) with higher accuracy according to the supplied liquid. Further, by determining the presence or absence of the temperature sensor 656 for detecting the liquid temperature and the heater temperature detecting portion originally necessary for the treatment, it is not necessary to separately provide a sensor or the like, and it is determined whether or not the heating circuits 65 and 75 are attached. The function to perform can be realized at low cost.

(実施の形態のまとめ)
次に、以上説明した実施の形態から把握される技術思想について、実施の形態における符号等を援用して記載する。ただし、以下の記載における各符号等は、特許請求の範囲における構成要素を実施の形態に具体的に示した部材等に限定するものではない。
(Summary of Embodiments)
Next, the technical idea grasped from the embodiment described above will be described with reference to the reference numerals and the like in the embodiment. However, the reference numerals and the like in the following description are not intended to limit the constituent elements in the claims to the members and the like specifically shown in the embodiments.

[1]患者の血液を体外循環させる血液回路(2)と、前記血液回路(2)、あるいは前記血液回路(2)に設けられた血液浄化器(3)に供給液を供給する液供給回路(4)と、前記液供給回路(4)に設けられ、供給液を加温する加温器(65,75)と、を備え、前記加温器(65,75)は、前記液供給回路(4)の一部である加温用回路(66)を挟持するように構成されており、前記加温用回路(66)を狭持する狭持面(651a)に設けられたヒータ(654)と、前記ヒータ(654)の温度を検出可能なヒータ温度検出部と、前記狭持面(651a)の前記ヒータ(654)と離間した位置であって、かつ、前記加温用回路(66)を狭持した際に、前記ヒータ(654)により加温される部分よりも送液方向下流側の前記加温用回路(66)に当接する位置に設けられ、前記加温用回路(66)を流れる供給液の温度を検出可能な液温検出用温度センサ(656)と、を有する、血液浄化装置(1)。 [1] A blood circuit (2) for extracorporeally circulating a patient's blood, and a liquid supply circuit for supplying a supply liquid to the blood circuit (2) or a blood purifier (3) provided in the blood circuit (2). (4) and a warmer (65, 75) provided in the liquid supply circuit (4) for heating the supply liquid, wherein the warmer (65, 75) is the liquid supply circuit. The heater (654) is configured to hold the heating circuit (66) which is a part of (4), and is provided on the holding surface (651a) that holds the heating circuit (66). ), a heater temperature detection unit capable of detecting the temperature of the heater (654), and a position separated from the heater (654) of the sandwiching surface (651a), and the heating circuit (66). ) Is held, the heating circuit (66) is provided at a position where the heating circuit (66) comes into contact with the heating circuit (66) downstream of the portion heated by the heater (654) in the liquid feeding direction. Blood temperature purifying device (1) having a liquid temperature detecting temperature sensor (656) capable of detecting the temperature of the supply liquid flowing through the liquid purifying device (1).

[2]前記ヒータ温度検出部で検出した前記ヒータ(654)の温度と、前記液温検出用温度センサ(656)で検出した供給液の温度とを基に、前記加温用回路(66)の前記加温器(65,75)への装着の有無を検知する加温器装着検知部(94)を備えた、[1]に記載の血液浄化装置(1)。 [2] Based on the temperature of the heater (654) detected by the heater temperature detection unit and the temperature of the supply liquid detected by the liquid temperature detection temperature sensor (656), the heating circuit (66) The blood purification device (1) according to [1], further comprising a warmer mounting detection unit (94) for detecting whether or not the warming device (65, 75) is mounted.

[3]前記加温器装着検知部(94)は、前記加温器(65,75)が加温を開始した後、前記ヒータ温度検出部が検出した温度が所定の上限温度に到達し、かつ、前記加温器(65,75)の加温開始時からの前記液温検出用温度センサ(656)の検出温度の上昇が、所定の異常判定閾値未満であるとき、前記加温用回路(66)が前記加温器(65,75)に装着されていないと判定する、[2]に記載の血液浄化装置(1)。 [3] The warmer mounting detection unit (94), after the warmer (65, 75) starts heating, the temperature detected by the heater temperature detection unit reaches a predetermined upper limit temperature, When the rise in the temperature detected by the liquid temperature detecting temperature sensor (656) from the start of heating of the warmer (65, 75) is less than a predetermined abnormality determination threshold value, the warming circuit. The blood purification device (1) according to [2], which determines that (66) is not attached to the warmer (65, 75).

[4]前記液温検出用温度センサ(656)で検出した供給液の温度が、予め設定された設定温度となるように、前記ヒータ(654)の温度を制御するヒータ制御部(93)を備え、前記ヒータ制御部(93)は、使用する供給液に応じて、前記ヒータ温度の上限値を設定可能に構成されている、[1]乃至[3]の何れか1項に記載の血液浄化装置(1)。 [4] A heater control unit (93) for controlling the temperature of the heater (654) so that the temperature of the supply liquid detected by the liquid temperature detection temperature sensor (656) becomes a preset temperature. The blood according to any one of [1] to [3], wherein the heater control section (93) is configured to be able to set an upper limit value of the heater temperature according to a supply liquid to be used. Purification device (1).

[5]前記ヒータ制御部(93)は、使用する供給液が蛋白質成分を含むか否かに応じて、前記上限温度を変更可能に構成されている、[4]に記載の血液浄化装置(1)。 [5] The blood purification device according to [4], wherein the heater control unit (93) is configured to be able to change the upper limit temperature according to whether or not the supply liquid to be used contains a protein component. 1).

[6]使用する供給液が蛋白質成分を含む場合、前記上限温度が46度未満とされ、使用する供給液が蛋白質成分を含まない場合、前記上限温度が46度以上とされる、[5]に記載の血液浄化装置(1)。 [6] When the feed solution used contains a protein component, the upper limit temperature is lower than 46 degrees, and when the feed solution used does not contain a protein component, the upper limit temperature is set to 46 degrees or higher, [5] Blood purification apparatus (1) according to 1.

[7]前記ヒータ温度検出部が、前記ヒータ(654)の加温領域内に設けられたヒータ用温度センサ(655)である、[1]乃至[6]の何れか1項に記載の血液浄化装置(1)。 [7] The blood according to any one of [1] to [6], wherein the heater temperature detection unit is a heater temperature sensor (655) provided in a heating region of the heater (654). Purification device (1).

以上、本発明の実施の形態を説明したが、上記に記載した実施の形態は特許請求の範囲に係る発明を限定するものではない。また、実施の形態の中で説明した特徴の組合せの全てが発明の課題を解決するための手段に必須であるとは限らない点に留意すべきである。本発明は、その趣旨を逸脱しない範囲で適宜変形して実施することが可能である。 Although the embodiments of the present invention have been described above, the embodiments described above do not limit the invention according to the claims. Further, it should be noted that not all combinations of the features described in the embodiments are essential to the means for solving the problems of the invention. The present invention can be appropriately modified and implemented without departing from the spirit of the present invention.

1…血液浄化装置
2…血液回路
3…血液浄化器
4…液供給回路
5…排液回路
6…透析液回路
65…透析液加温器(加温器)
654…ヒータ
655…ヒータ用温度センサ
656…液温検出用温度センサ
66…加温用回路
7…補充液回路
75…補充液加温器(加温器)
9…制御装置
93…ヒータ制御部
94…加温器装着検知部
DESCRIPTION OF SYMBOLS 1... Blood purification device 2... Blood circuit 3... Blood purification device 4... Liquid supply circuit 5... Drainage circuit 6... Dialysate circuit 65... Dialysate warmer (warmer)
654... Heater 655... Heater temperature sensor 656... Liquid temperature detecting temperature sensor 66... Heating circuit 7... Replenishing liquid circuit 75... Replenishing liquid warmer (warmer)
9... Control device 93... Heater control unit 94... Warmer attachment detection unit

Claims (7)

患者の血液を体外循環させる血液回路と、
前記血液回路、あるいは前記血液回路に設けられた血液浄化器に供給液を供給する液供給回路と、
前記液供給回路に設けられ、供給液を加温する加温器と、を備え、
前記加温器は、
前記液供給回路の一部である加温用回路を挟持するように構成されており、
前記加温用回路を狭持する狭持面に設けられたヒータと、
前記ヒータの温度を検出可能なヒータ温度検出部と、
前記狭持面の前記ヒータと離間した位置であって、かつ、前記加温用回路を狭持した際に、前記ヒータにより加温される部分よりも送液方向下流側の前記加温用回路に当接する位置に設けられ、前記加温用回路を流れる供給液の温度を検出可能な液温検出用温度センサと、を有する、
血液浄化装置。
A blood circuit for circulating the patient's blood extracorporeally,
A liquid supply circuit for supplying a supply liquid to the blood circuit, or a blood purifier provided in the blood circuit,
A warmer provided in the liquid supply circuit for heating the supply liquid;
The warmer is
It is configured to sandwich a heating circuit which is a part of the liquid supply circuit,
A heater provided on a holding surface for holding the heating circuit,
A heater temperature detection unit capable of detecting the temperature of the heater;
The heating circuit at a position separated from the heater on the sandwiching surface, and on the downstream side in the liquid feeding direction of the portion heated by the heater when the heating circuit is sandwiched. A temperature sensor for liquid temperature detection, which is provided at a position abutting on the temperature sensor and is capable of detecting the temperature of the supply liquid flowing through the heating circuit.
Blood purification device.
前記ヒータ温度検出部で検出した前記ヒータの温度と、前記液温検出用温度センサで検出した供給液の温度とを基に、前記加温用回路の前記加温器への装着の有無を検知する加温器装着検知部を備えた、
請求項1に記載の血液浄化装置。
Whether or not the heating circuit is attached to the warmer is detected based on the temperature of the heater detected by the heater temperature detection unit and the temperature of the supply liquid detected by the temperature sensor for liquid temperature detection. Equipped with a warmer attachment detection unit
The blood purification apparatus according to claim 1.
前記加温器装着検知部は、前記加温器が加温を開始した後、前記ヒータ温度検出部が検出した温度が所定の上限温度に到達し、かつ、前記加温器の加温開始時からの前記液温検出用温度センサの検出温度の上昇が、所定の異常判定閾値未満であるとき、前記加温用回路が前記加温器に装着されていないと判定する、
請求項2に記載の血液浄化装置。
The warming device mounting detection unit, when the temperature detected by the heater temperature detection unit reaches a predetermined upper limit temperature after the heating unit starts heating, and when the heating of the heating unit is started. When the increase in the temperature detected by the liquid temperature detecting temperature sensor from is less than a predetermined abnormality determination threshold value, it is determined that the heating circuit is not mounted on the warmer,
The blood purification apparatus according to claim 2.
前記液温検出用温度センサで検出した供給液の温度が、予め設定された設定温度となるように、前記ヒータの温度を制御するヒータ制御部を備え、
前記ヒータ制御部は、使用する供給液に応じて、前記ヒータ温度の上限値を設定可能に構成されている、
請求項1乃至3の何れか1項に記載の血液浄化装置。
The temperature of the supply liquid detected by the temperature sensor for detecting the liquid temperature is provided with a heater control unit that controls the temperature of the heater so as to be a preset temperature.
The heater control unit is configured to be able to set an upper limit value of the heater temperature according to the supply liquid used.
The blood purification apparatus according to any one of claims 1 to 3.
前記ヒータ制御部は、使用する供給液が蛋白質成分を含むか否かに応じて、前記上限温度を変更可能に構成されている、
請求項4に記載の血液浄化装置。
The heater control unit is configured to be able to change the upper limit temperature according to whether or not the supply liquid used contains a protein component.
The blood purification apparatus according to claim 4.
使用する供給液が蛋白質成分を含む場合、前記上限温度が46度未満とされ、使用する供給液が蛋白質成分を含まない場合、前記上限温度が46度以上とされる、
請求項5に記載の血液浄化装置。
When the feed solution used contains a protein component, the upper limit temperature is less than 46 degrees, when the feed solution used does not contain a protein component, the upper limit temperature is 46 degrees or more,
The blood purification apparatus according to claim 5.
前記ヒータ温度検出部が、前記ヒータの加温領域内に設けられたヒータ用温度センサである、
請求項1乃至6の何れか1項に記載の血液浄化装置。
The heater temperature detection unit is a heater temperature sensor provided in a heating region of the heater,
The blood purification apparatus according to any one of claims 1 to 6.
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